Carac & PDT Combination in the Treatment Of Actinic Keratoses
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
To demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone. This will be done by manual counts and through photography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2008
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedDecember 2, 2024
November 1, 2024
2.7 years
April 19, 2016
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of Actinic Keratoses
The objective of this study is to demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone based on a manual lesion count.
Outcomes are assessed at 3 months
Secondary Outcomes (1)
Photographic Improvement of Actinic Keratoses
Outcomes are assessed at 3 months
Study Arms (3)
1
ACTIVE COMPARATORCarac
2
ACTIVE COMPARATORPhotodynamic Therapy
3
ACTIVE COMPARATORCarac combined with Photodynamic Therapy
Interventions
Carac (fluorouracil) Cream, 0.5% is used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis.
Photodynamic therapy (PDT) is a procedure that uses a photosensitizing drug to apply light therapy selectively to target pre-skin cancer, acne and sun damage.
Eligibility Criteria
You may qualify if:
- Males/females,, aged 40-70
- Must have 5 or more documented facial/anterior scalp actinic keratoses
- Read, understood, and signed informed consent form
- Willing and able to comply with all follow-up requirements
You may not qualify if:
- Previous treatment of facial keratoses with any modality of treatment within 3 months of study enrollment
- Contraindications to the use of either Carac and/or PDT treatment
- Active infections or dermatitis in the treatment area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skin Laser & Surgery Specialistslead
- Sanoficollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2016
First Posted
December 2, 2024
Study Start
August 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
December 2, 2024
Record last verified: 2024-11